Job Title: QA Generalist

Job Description

The QA Generalist is a key member of the Quality & Compliance team, reporting to the Director, Quality Assurance Operations. This role is essential in maintaining high-quality standards in alignment with applicable laws, regulations, and company policies and procedures. The QA Generalist supports quality assurance processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams to uphold product integrity and safety. This position requires a strong understanding of laboratory and manufacturing environments within the biotechnology industry.

Responsibilities

• Perform batch record review and release in support of US and ex-US clinical trials.
• Investigate and address product quality issues, including deviations, OOS results, and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization.
• Provide Quality support to CMC throughout the product lifecycle.
• Implement, maintain, and improve the Quality Management System (QMS) in accordance with internal policies and procedures, regulatory requirements, and industry standards.
• Assist in the creation and maintenance of SOPs, policies, and associated documents.
• Compile metrics for internal and external operations.
• Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls.
• Ensure all documentation is accurate, complete, and compliant with internal policies and procedures and regulatory standards.
• Assist in preparing for internal and external audits.
• Support the execution of internal audits to ensure compliance with regulatory standards.
• Address and resolve audit findings, ensuring corrective actions are implemented.
• Assist in the preparation of regulatory filings and submissions.
• Perform other related duties as assigned.

Essential Skills

• Extensive knowledge of GMP, GCP ICH, and US/EU/UK regulations.
• Experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control, or Quality Engineering positions.
• Demonstrated knowledge of Quality Management Systems, preferably electronic systems.
• Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a related field.
• Minimum of 4 years’ experience in biopharmaceutical operations, technical operations, and/or quality operations, with 2 years hands-on experience in Quality function supporting clinical or commercial batch release.
• Experience supporting product technical transfer activities and comparability studies.
• Experience with audit processes, document control, and Quality Management Systems: deviations, change control management, and CAPAs.
• Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships.
• Effective presentation and writing skills.
• Ability to provide clear, pragmatic direction and advice regarding compliance issues.
• Highly organized and able to work independently.
• Strong team orientation and passion for continuous self-development.

Additional Skills & Qualifications

• Cell and gene therapy experience preferred.
• Experience in a startup environment preferred.

Work Environment

The position offers flexible hours, primarily first shift, with the ability to work remotely. The QA Generalist will work with a team of 2 others within the QMS, including a manager and a director. The biotech company is working towards pivotal trials, providing an exciting and dynamic work environment. Leadership has remained consistent over the past 8 years. The position includes benefits such as accrued PTO, holiday pay, and accrued sick pay.

Pay and Benefits

The pay range for this position is $32.00 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Philadelphia,PA.

Application Deadline

This position is anticipated to close on Feb 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $32 - $40